Manaf Al Hashimi et al., 2024: Regenerative Therapy in Erectile Dysfunction: A Survey on Current Global Practice Trends and Recommendations

Monday, 23 December 2024

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Manaf Al Hashimi 1 2 3, Germar-M Pinggera 3 4, Taymour Mostafa 3 5, Amarnath Rambhatla 3 6, Taha Hamoda 3 7 8, Rupin Shah 3 9, Eric Chung 3 10, Ahmed Harraz 3 11 12 13, Mohamed Arafa 3 5 14 15, Tuncay Toprak 3 16, Omer Raheem 3 17, Carlo Giulioni 3 18, Ponco Birowo 3 19, Luca Boeri 3 20, Yassir Jassim 3 21, Priyank Kothari 3 22, Ranjit Vishwakarma 3 9, Bahadir Sahin 3 23, Widi Atmoko 3 19, Safar Gamidov 3 24, Cesar Rojas-Cruz 3 25, Darren Katz 3 26 27 28, Adriano Fregonesi 3 29, Nazim Gherabi 3 30, Armand Zini 3 31, Christopher Chee Kong Ho 3 32, Mohamed S Al-Marhoon 3 33, Marlon Martinez 3 34, Giorgio Ivan Russo 3 35, Ayman Rashed 3 36, Gian Maria Busetto 3 37, Edmund Ko 3 38, Hyun Jun Park 3 39 40, Selahittin Cayan 3 41, Ramadan Saleh 3 42, Osvaldo Rajmil 3 43, Dong Suk Kim 3 44, Giovanni Colpi 3 45, Ryan Smith 3 46, Maged Ragab 3 47, Ates Kadioglu 3 48, Quang Nguyen 3 49 50, Kadir Bocu 3 51, Ahmed El-Sakka 3 52, Charalampos Thomas 3 53, Hussain M Alnajjar 3 54, Hiva Alipour 3 55, Ashok Agarwal 3 56
1Department of Urology, Burjeel Hospital, Abu Dhabi, UAE.
2Department of Clinical Urology, College of Medicine and Health Science, Khalifa University, Abu Dhabi, UAE.
3Global Andrology Forum, Moreland Hills, OH, USA.
4Department of Urology, Innsbruck Medical University, Innsbruck, Austria.
5Department of Andrology, Sexology & STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.
6Department of Urology, Henry Ford Health System, Vattikuti Urology Institute, Detroit, MI, USA.
7Department of Urology, King Abdulaziz University, Jeddah, Saudi Arabia.
8Department of Urology, Faculty of Medicine, Minia University, Minia, Egypt.
9Division of Andrology, Department of Urology, Lilavati Hospital and Research Centre, Mumbai, India.
10Department of Urology, Princess Alexandra Hospital, University of Queensland, Brisbane, Australia.
11Department of Urology, Mansoura University Urology and Nephrology Center, Mansoura, Egypt.
12Department of Surgery, Urology Unit, Farwaniya Hospital, Farwaniya, Kuwait.
13Department of Urology, Sabah Al Ahmad Urology Center, Kuwait City, Kuwait.
14Department of Urology, Hamad Medical Corporation, Doha, Qatar.
15Department of Urology, Weill Cornell Medical-Qatar, Doha, Qatar.
16Department of Urology, Fatih Sultan Mehmet Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye.
17Section of Urology, University of Chicago, Chicago, IL, USA.
18Department of Urology, Polytechnic University of Marche Region, Ancona, Italy.
19Department of Urology, Dr. Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
20Department of Urology, IRCCS Fondazione Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
21Department of Urology, Canadian Specialist Hospital, Dubai, UAE.
22Department of Urology, B.Y.L Nair Ch Hospital, Topiwala National Medical College, Mumbai, India.
23Department of Urology, Marmara University School of Medicine, Istanbul, Türkiye.
24Deparment of Urology, Kulakov National Medical Research, Moscow, Russia.
25Department of Urology, University Hospital of Rostock, Rostock, Germany.
26Department of Urology, Men's Health Melbourne, Victoria, Australia.
27Department of Surgery, Western Precinct, University of Melbourne, Victoria, Australia.
28Department of Urology, Western Health, Victoria, Australia.
29Discipline of Urology, Department of Surgery, School of Medicine, Universida de Estadual de Campina, Sao Paolo, Brazil.
30Department of Medicine, University of Algiers 1, Algiers, Algeria.
31Department of Surgery, McGill University, Montreal, QC, Canada.
32Department of Surgery, School of Medicine, Taylor's University, Selangor, Malaysia.
33Division of Urology, Department of Surgery, Sultan Qaboos University, Muscat, Oman.
34Section of Urology, Department of Surgery, University of Santo Tomas Hospital, Manila, Philippines.
35Urology Section, University of Catania, Catania, Italy.
36Department of Urology and Andrology, October 6th University, Cairo, Egypt.
37Department of Urology and Renal Transplantation, University of Foggia, Foggia, Italy.
38Department of Urology, Kaiser Permanente, Fontana, CA, USA.
39Department of Urology, Pusan National University School of Medicine, Busan, Korea.
40Medical Research Institute, Pusan National University Hospital, Busan, Korea.
41Department of Urology, University of Mersin School of Medicine, Mersin, Türkiye.
42Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University, Sohag, Egypt.
43Department of Andrology, Fundacio Puigvert, Barcelona, Spain.
44Department of Urology, CHA Gangnam Medical Center, CHA University, Seoul, Korea.
45Andrology and IVF Center, Next Fertility Procrea, Lugano, Switzerland.
46Department of Urology, University of Virginia School of Medicine, Charlottesville, VA, USA.
47Urology Department, Tanta University, Tanta, Egypt.
48Section of Andrology, Department of Urology, Istanbul School of Medicine, Istanbul, Türkiye.
49Center for Andrology and Sexual Medicine, Viet Duc University Hospital, Hanoi, Vietnam.
50Department of Urology, Andrology and Sexual Medicine, University of Medicine and Pharmacy, Vietnam National University, Hanoi, Vietnam.
51Department of Urology, Niğde Omer Halisdemir University, Niğde, Türkiye.
52Department of Urology, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.
53Department of Urology, General Hospital of Corinth, Corinthia, Greece.
54Department of Urology, University College London Hospital, London, UK.
55Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
56Cleveland Clinic Foundation, Cleveland, OH, USA.

Abstract

Purpose: This study aimed to examine current global practices in regenerative therapy (RT) for erectile dysfunction (ED) and to establish expert recommendations for its use, addressing the current lack of solid evidence and standardized guidelines.

Materials and methods: A 39-question survey was developed by senior Global Andrology Forum (GAF) experts to comprehensively cover clinical aspects of RT. This was distributed globally via a secure online Google Form to ED specialists through the GAF website, international professional societies, and social media, the responses were analyzed and presented for frequencies as percentages. Consensus on expert recommendations for RT use was achieved using the Delphi method.

Results: Out of 479 respondents from 62 countries, a third reported using RT for ED. The most popular treatment was low-intensity shock wave therapy (54.6%), followed by platelet-rich plasma (24.5%) and their combination (14.7%), with stem cell therapy being the least used (3.7%). The primary indication for RT was the refractory or adverse effects of PDE5 inhibitors, with the best effectiveness reported in middle-aged and mild-to-moderate ED patients. Respondents were confident about its overall safety, with a significant number expressing interest in RT's future use, despite pending guidelines support.

Conclusions: This inaugural global survey reveals a growing use of RT in ED treatment, showcasing its diverse clinical applications and potential for future widespread adoption. However, the lack of comprehensive evidence and clear guidelines requires further research to standardize RT practices in ED treatment.

World J Mens Health. 2024 Jul 12. doi: 10.5534/wjmh.240086. Online ahead of print.
PMID: 39028131 FREE ARTICLE

Comments 1

Jens Rassweiler on Monday, 23 December 2024 10:00

This study aimed to examine current global practices in regenerative therapy (RT) for erectile dysfunction (ED) and to establish expert recommendations for its use, addressing the current lack of solid evidence and standardized guidelines. A 39-question survey was developed by senior Global Andrology Forum (GAF) experts to comprehensively cover clinical aspects of RT. This was distributed globally via a secure online Google Form to ED specialists through the GAF website, international professional societies, and social media, the responses were analyzed and presented for frequencies as percentages.
Overview of ED and Standard Treatments
Erectile dysfunction (ED) is a common condition with increasing prevalence, largely due to aging populations. Current treatments like PDE5 inhibitors (PDE5i), intracavernosal injections, vacuum devices, and penile prosthesis provide symptomatic relief but fail to restore natural erectile function. Regenerative therapy (RT) aims to repair and regenerate erectile tissues, offering a potential cure rather than temporary relief.
Key Regenerative Therapy Modalities include
1. Platelet-Rich Plasma (PRP):
o Autologous plasma enriched with growth factors.
o Shows promise in diabetic patients but requires more robust studies on preparation quality and long-term outcomes.
2. Stem Cell Therapy (SC):
o Undifferentiated cells can replace damaged tissues.
o Evidence supports its efficacy, especially in diabetic ED and penile fibrosis, but clinical data is limited. Adipose-derived SCs may be more effective than bone marrow-derived ones.
3. Low-Intensity Shock Wave Therapy (LISWT):
o Stimulates vascular growth and improves penile hemodynamics.
o Meta-analyses indicate significant improvements in erectile function scores with long-term safety demonstrated.
Global Practice Trends are
• Only 34% of clinicians surveyed use RT, with limited experience or institutional access being the main barriers.
• LISWT is the most commonly used (74.8%), followed by PRP (18.4%) and SC (3.7%).
• Most common reasons include resistance to standard treatments (63.8%) and patient interest in innovative therapies (14.1%).
Effectiveness and Patient Satisfaction
Satisfaction levels vary: 50.3% report moderate satisfaction, while only 24.5% observe significant objective improvements in over half of their patients. Duration of benefits ranges from 1–3 months (11.7%) to over 12 months (16%), with most patients (93.2%) experiencing effects within 6 months post-treatment. It has to be taken into consideration, that these data are not based on a controlled study!
Comparison with PDE5i
• Advantages: Better long-term outcomes, improved efficacy, and fewer side effects.
• Drawbacks: Higher costs and mixed opinions on cost-effectiveness.
Assessment and Best Responders
Effectiveness is often assessed subjectively (58.3% rely on patient satisfaction). Middle-aged patients and those with moderate ED show the best response to RT. Objective evaluations like penile Doppler ultrasound are underutilized (20.9%).
Discussion
The discussion section offers an insightful overview of global practices and attitudes towards regenerative therapies (RT) in the treatment of erectile dysfunction (ED).
Survey Scope and Respondents: This was the first global survey targeting sexual medicine practitioners' views on RT for ED. Most respondents were involved in ED management but treated ED patients in less than 25% of their clinical practice.
ED Presentation and Diagnosis: ED causes are multifactorial, including psychogenic and organic factors. Vasculogenic issues are prominent, particularly among younger men, alongside structural conditions like Peyronie's disease. Diagnostic approaches typically combined history, examination, hormonal testing, and penile Doppler ultrasound.
Use and Effectiveness of RT: The existing literature shows the following
Low-Intensity Shockwave Therapy (LISWT): The most commonly used RT modality, showing promise in improving outcomes for mild-to-moderate vasculogenic ED and those not responding to PDE5 inhibitors. Combination treatments (e.g., LISWT + tadalafil) yielded better results than LISWT alone.Limitations include the need for more long-term randomized clinical trials.
Platelet-Rich Plasma (PRP): The second-most preferred therapy. Early results suggest benefits, but heterogeneity in preparation protocols and lack of placebo-controlled studies hinder its widespread acceptance.
Stem Cell (SC) Therapy: Used minimally (3.68%) due to cost, unavailability, and regulatory constraints. Early studies suggest potential, but evidence is limited and protocols are not standardized.
Practitioner Trends: RT is more popular among younger practitioners and those interested in innovative treatments, while established therapies like oral medications and injections remain the standard. Insurance non-coverage, lack of experience, and unavailability limit RT usage.
Limitations of the Study
Survey reliance on subjective assessments rather than objective metrics like Doppler ultrasound or validated scores.Low participation in SC therapy research due to cost and institutional hurdles. Limited data availability on RT efficacy in severe ED cases.
Implications and Future Directions
There is a growing acceptance of RT in ED management, particularly LISWT. PRP and SC therapies are still in experimental stages but hold potential with standardized protocols and more clinical trials. Practitioners need more training and clearer guidance from professional societies. Insurance coverage and robust evidence will be critical to integrating RT into mainstream treatment.
Conclusion
Regenerative therapies have potential for managing ED, especially mild-to-moderate cases, but more research is needed to establish them as standard care. LISWT has seen increasing popularity, whereas PRP and SC therapies remain experimental. Clearer protocols, clinician training, and insurance support are essential for broader adoption. The discussion highlights the dynamic landscape of ED treatment, with RT offering hope for more holistic solutions but requiring robust validation through future research.

Jens Rassweiler

This study aimed to examine current global practices in regenerative therapy (RT) for erectile dysfunction (ED) and to establish expert recommendations for its use, addressing the current lack of solid evidence and standardized guidelines. A 39-question survey was developed by senior Global Andrology Forum (GAF) experts to comprehensively cover clinical aspects of RT. This was distributed globally via a secure online Google Form to ED specialists through the GAF website, international professional societies, and social media, the responses were analyzed and presented for frequencies as percentages. 
Overview of ED and Standard Treatments
Erectile dysfunction (ED) is a common condition with increasing prevalence, largely due to aging populations. Current treatments like PDE5 inhibitors (PDE5i), intracavernosal injections, vacuum devices, and penile prosthesis provide symptomatic relief but fail to restore natural erectile function. Regenerative therapy (RT) aims to repair and regenerate erectile tissues, offering a potential cure rather than temporary relief.
Key Regenerative Therapy Modalities include
1.	Platelet-Rich Plasma (PRP):
o	Autologous plasma enriched with growth factors.
o	Shows promise in diabetic patients but requires more robust studies on preparation quality and long-term outcomes.
2.	Stem Cell Therapy (SC):
o	Undifferentiated cells can replace damaged tissues.
o	Evidence supports its efficacy, especially in diabetic ED and penile fibrosis, but clinical data is limited. Adipose-derived SCs may be more effective than bone marrow-derived ones.
3.	Low-Intensity Shock Wave Therapy (LISWT):
o	Stimulates vascular growth and improves penile hemodynamics.
o	Meta-analyses indicate significant improvements in erectile function scores with long-term safety demonstrated.
Global Practice Trends are
•	Only 34% of clinicians surveyed use RT, with limited experience or institutional access being the main barriers.
•	LISWT is the most commonly used (74.8%), followed by PRP (18.4%) and SC (3.7%).
•	Most common reasons include resistance to standard treatments (63.8%) and patient interest in innovative therapies (14.1%).
Effectiveness and Patient Satisfaction
Satisfaction levels vary: 50.3% report moderate satisfaction, while only 24.5% observe significant objective improvements in over half of their patients. Duration of benefits ranges from 1–3 months (11.7%) to over 12 months (16%), with most patients (93.2%) experiencing effects within 6 months post-treatment. It has to be taken into consideration, that these data are not based on a controlled study!
Comparison with PDE5i
•	Advantages: Better long-term outcomes, improved efficacy, and fewer side effects.
•	Drawbacks: Higher costs and mixed opinions on cost-effectiveness.
Assessment and Best Responders
Effectiveness is often assessed subjectively (58.3% rely on patient satisfaction). Middle-aged patients and those with moderate ED show the best response to RT. Objective evaluations like penile Doppler ultrasound are underutilized (20.9%).
Discussion
The discussion section offers an insightful overview of global practices and attitudes towards regenerative therapies (RT) in the treatment of erectile dysfunction (ED). 
Survey Scope and Respondents: This was the first global survey targeting sexual medicine practitioners' views on RT for ED. Most respondents were involved in ED management but treated ED patients in less than 25% of their clinical practice.
ED Presentation and Diagnosis: ED causes are multifactorial, including psychogenic and organic factors. Vasculogenic issues are prominent, particularly among younger men, alongside structural conditions like Peyronie's disease. Diagnostic approaches typically combined history, examination, hormonal testing, and penile Doppler ultrasound.
Use and Effectiveness of RT: The existing literature shows the following
Low-Intensity Shockwave Therapy (LISWT): The most commonly used RT modality, showing promise in improving outcomes for mild-to-moderate vasculogenic ED and those not responding to PDE5 inhibitors. Combination treatments (e.g., LISWT + tadalafil) yielded better results than LISWT alone.Limitations include the need for more long-term randomized clinical trials.
Platelet-Rich Plasma (PRP): The second-most preferred therapy. Early results suggest benefits, but heterogeneity in preparation protocols and lack of placebo-controlled studies hinder its widespread acceptance.
Stem Cell (SC) Therapy: Used minimally (3.68%) due to cost, unavailability, and regulatory constraints. Early studies suggest potential, but evidence is limited and protocols are not standardized.
Practitioner Trends: RT is more popular among younger practitioners and those interested in innovative treatments, while established therapies like oral medications and injections remain the standard. Insurance non-coverage, lack of experience, and unavailability limit RT usage.
Limitations of the Study
Survey reliance on subjective assessments rather than objective metrics like Doppler ultrasound or validated scores.Low participation in SC therapy research due to cost and institutional hurdles. Limited data availability on RT efficacy in severe ED cases.
Implications and Future Directions
There is a growing acceptance of RT in ED management, particularly LISWT. PRP and SC therapies are still in experimental stages but hold potential with standardized protocols and more clinical trials. Practitioners need more training and clearer guidance from professional societies. Insurance coverage and robust evidence will be critical to integrating RT into mainstream treatment.
Conclusion
Regenerative therapies have potential for managing ED, especially mild-to-moderate cases, but more research is needed to establish them as standard care. LISWT has seen increasing popularity, whereas PRP and SC therapies remain experimental. Clearer protocols, clinician training, and insurance support are essential for broader adoption. The discussion highlights the dynamic landscape of ED treatment, with RT offering hope for more holistic solutions but requiring robust validation through future research.

Jens Rassweiler

This study aimed to examine current global practices in regenerative therapy (RT) for erectile dysfunction (ED) and to establish expert recommendations for its use, addressing the current lack of solid evidence and standardized guidelines. A 39-question survey was developed by senior Global Andrology Forum (GAF) experts to comprehensively cover clinical aspects of RT. This was distributed globally via a secure online Google Form to ED specialists through the GAF website, international professional societies, and social media, the responses were analyzed and presented for frequencies as percentages. Overview of ED and Standard Treatments Erectile dysfunction (ED) is a common condition with increasing prevalence, largely due to aging populations. Current treatments like PDE5 inhibitors (PDE5i), intracavernosal injections, vacuum devices, and penile prosthesis provide symptomatic relief but fail to restore natural erectile function. Regenerative therapy (RT) aims to repair and regenerate erectile tissues, offering a potential cure rather than temporary relief. Key Regenerative Therapy Modalities include 1. Platelet-Rich Plasma (PRP): o Autologous plasma enriched with growth factors. o Shows promise in diabetic patients but requires more robust studies on preparation quality and long-term outcomes. 2. Stem Cell Therapy (SC): o Undifferentiated cells can replace damaged tissues. o Evidence supports its efficacy, especially in diabetic ED and penile fibrosis, but clinical data is limited. Adipose-derived SCs may be more effective than bone marrow-derived ones. 3. Low-Intensity Shock Wave Therapy (LISWT): o Stimulates vascular growth and improves penile hemodynamics. o Meta-analyses indicate significant improvements in erectile function scores with long-term safety demonstrated. Global Practice Trends are • Only 34% of clinicians surveyed use RT, with limited experience or institutional access being the main barriers. • LISWT is the most commonly used (74.8%), followed by PRP (18.4%) and SC (3.7%). • Most common reasons include resistance to standard treatments (63.8%) and patient interest in innovative therapies (14.1%). Effectiveness and Patient Satisfaction Satisfaction levels vary: 50.3% report moderate satisfaction, while only 24.5% observe significant objective improvements in over half of their patients. Duration of benefits ranges from 1–3 months (11.7%) to over 12 months (16%), with most patients (93.2%) experiencing effects within 6 months post-treatment. It has to be taken into consideration, that these data are not based on a controlled study! Comparison with PDE5i • Advantages: Better long-term outcomes, improved efficacy, and fewer side effects. • Drawbacks: Higher costs and mixed opinions on cost-effectiveness. Assessment and Best Responders Effectiveness is often assessed subjectively (58.3% rely on patient satisfaction). Middle-aged patients and those with moderate ED show the best response to RT. Objective evaluations like penile Doppler ultrasound are underutilized (20.9%). Discussion The discussion section offers an insightful overview of global practices and attitudes towards regenerative therapies (RT) in the treatment of erectile dysfunction (ED). Survey Scope and Respondents: This was the first global survey targeting sexual medicine practitioners' views on RT for ED. Most respondents were involved in ED management but treated ED patients in less than 25% of their clinical practice. ED Presentation and Diagnosis: ED causes are multifactorial, including psychogenic and organic factors. Vasculogenic issues are prominent, particularly among younger men, alongside structural conditions like Peyronie's disease. Diagnostic approaches typically combined history, examination, hormonal testing, and penile Doppler ultrasound. Use and Effectiveness of RT: The existing literature shows the following Low-Intensity Shockwave Therapy (LISWT): The most commonly used RT modality, showing promise in improving outcomes for mild-to-moderate vasculogenic ED and those not responding to PDE5 inhibitors. Combination treatments (e.g., LISWT + tadalafil) yielded better results than LISWT alone.Limitations include the need for more long-term randomized clinical trials. Platelet-Rich Plasma (PRP): The second-most preferred therapy. Early results suggest benefits, but heterogeneity in preparation protocols and lack of placebo-controlled studies hinder its widespread acceptance. Stem Cell (SC) Therapy: Used minimally (3.68%) due to cost, unavailability, and regulatory constraints. Early studies suggest potential, but evidence is limited and protocols are not standardized. Practitioner Trends: RT is more popular among younger practitioners and those interested in innovative treatments, while established therapies like oral medications and injections remain the standard. Insurance non-coverage, lack of experience, and unavailability limit RT usage. Limitations of the Study Survey reliance on subjective assessments rather than objective metrics like Doppler ultrasound or validated scores.Low participation in SC therapy research due to cost and institutional hurdles. Limited data availability on RT efficacy in severe ED cases. Implications and Future Directions There is a growing acceptance of RT in ED management, particularly LISWT. PRP and SC therapies are still in experimental stages but hold potential with standardized protocols and more clinical trials. Practitioners need more training and clearer guidance from professional societies. Insurance coverage and robust evidence will be critical to integrating RT into mainstream treatment. Conclusion Regenerative therapies have potential for managing ED, especially mild-to-moderate cases, but more research is needed to establish them as standard care. LISWT has seen increasing popularity, whereas PRP and SC therapies remain experimental. Clearer protocols, clinician training, and insurance support are essential for broader adoption. The discussion highlights the dynamic landscape of ED treatment, with RT offering hope for more holistic solutions but requiring robust validation through future research. Jens Rassweiler

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